NCT01488305

Brief Summary

Helen Keller International (HKI), the ministry of health and population, and ministry of agriculture and cooperatives, of Nepal and local non-governmental organizations (NGO) partners are currently implementing a USAID funded Action Against Malnutrition Through Agriculture (AAMA) project in Baitadi district located in far Western development region of Nepal. HKI is undertaking this study within the AAMA project to test whether providing micro-nutrient powders (MNPs) in a programmatic context along with homestead food production (HFP) and an intensive community level Infant and Young Child Feeding Behavior change communication (IYCF-BCC) intervention will have a greater impact on reducing anemia and improving growth in young children than only providing the HFP and IYCF-BCC intervention without MNPs or a control with no intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
334

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

August 28, 2019

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

December 5, 2011

Last Update Submit

August 22, 2019

Conditions

Keywords

MNPAAMA programNepalHFPIYCFBCC

Outcome Measures

Primary Outcomes (1)

  • Anemia

    All three arms anemia status will be compared after one year of MNP distribution (assess the additional value of MNP)

    One year

Secondary Outcomes (1)

  • Impact on growth of children

    one year

Study Arms (3)

Only government regular program

NO INTERVENTION

One arm is control arm, in this arm no additional program is added in government regular program

AAMA arm (HFP and IYCF BCC)

EXPERIMENTAL

Second arm is AAMA project intervention which includes HFP activities, ENA and BCC activities

Other: AAMA project activities (HFP and IYCF BCC)

MNP added in AAMA

EXPERIMENTAL

It is actually a intervention arm

Dietary Supplement: MNP (micro-nutrient powders)Other: AAMA project activities (HFP and IYCF BCC)

Interventions

MNP is added to explore the additional value of MNP in existing AAMA program

Also known as: MNP sub study in AAMA
MNP added in AAMA

This is the existing AAMA program

AAMA arm (HFP and IYCF BCC)MNP added in AAMA

Eligibility Criteria

Age6 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children 6-9 months of age during enrollment time
  • Mothers who want to enroll their children in study

You may not qualify if:

  • Severe anemia
  • Children age below six months and age over 23 months during study time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helen Keller International, Nepal

Baitadī, Nepal

Location

Related Links

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Pooja Pandey Rana, MPH

    Helen Keller International

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2011

First Posted

December 8, 2011

Study Start

October 1, 2010

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

August 28, 2019

Record last verified: 2011-12

Locations